Transcript

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cetirizine hydrochloride Tablets can cause side effects, although not everybody gets them.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without prescription. However, you still need to use Cetirizine hydrochloride Tablets carefully to get the best results from it.
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Keep this leaflet. You may need to read it again.
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Ask your pharmacist if you need more information or advice.
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You must contact a doctor if your symptoms worsen or do not improve after 3 days.
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If any of the side effects gets serious, or if you notice any side effects not listed in this leaﬂet, please tell your doctor or pharmacist.
What is in this leaflet:
1. What Cetirizine hydrochloride Tablets is and what it is used for
2. What you need to know before you take Cetirizine hydrochloride Tablets
3. How to take Cetirizine hydrochloride Tablets
4. Possible side effects
5. How to store Cetirizine hydrochloride Tablets
6. Contents of the pack and other information

The following side effect is very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice
these symptoms:
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A severe allergic reaction including rash, itchiness and fever, swollen throat, face, eyelids or lips. This reaction may start soon after you
ﬁrst take the medicine, or it might start later.

Cetirizine hydrochloride is the active ingredient of Cetirizine hydrochloride Tablets.
Cetirizine hydrochloride Tablets are an anti allergy medication.
In adults and children aged 6 years and above, Cetirizine hydrochloride Tablets is used:
For the relief of symptoms of seasonal (hayfever) and year round allergies (e.g. sneezing, running or itchy nose, watery eyes).
For the relief of chronic nettle rash.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE HYDROCHLORIDE TABLETS
Do not take Cetirizine hydrochloride Tablets:
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If you are allergic (hypersensitive) to Cetirizine hydrochloride, to any of the other ingredients of Cetirizine hydrochloride Tablets, to
hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
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If you have severe kidney problems.
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If you have or there is a family history of problems with galactose intolerance, the Lapp lactase deﬁciency or glucose-galactose
malabsorption.
Cetirizine hydrochloride Tablets are not for use in children under 6 years of age.
Take special care with Cetirizine hydrochloride Tablets
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If you have liver and kidney problems, please ask your doctor for advice; if necessary, your doctor may recommend a lower dose.
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When drinking alcohol while taking this medicine.
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If you are an epileptic patient or a patient at risk of convulsions (ﬁts), you should ask your doctor for advice.
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If you have predisposition factors of urinary retention (eg: spinalcord lesion, prostatic hyperplasia) as cetirizine increases the risk of
urinary retention.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a
prescription.
The available information on this medicine suggests no interactions with other medicines should be expected.
Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
Pregnancy and breast-feeding
Pregnancy: As with other drugs, use of Cetirizine hydrochloride Tablets should be avoided in pregnant women. Accidental use of the drug by a
pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the use of the medicine during pregnancy should be
discontinued.
Breast-feeding: Do not use this medicine while breast feeding because cetirizine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
A few people have experienced dizziness, drowsiness or fatigue after taking cetirizine. If affected, do not attempt any skilled task such as
driving or operating machinery. Do not exceed the recommended dose.
Take special care if you drink alcohol while taking Cetirizine hydrochloride Tablets- the effect may be increased. Never drink and then drive or
operate tools and machines.

Rare side effects (affects less than 1 in 1000 people)
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Fast heart beat
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Oedema (generalised swelling due to water retention)
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Abnormal liver function test results (your doctor will know what to do)
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Convulsions
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Increased weight
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Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
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Urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)
• Blurred vision, difﬁculty focussing
• Rotation of the eyes
• Unusual bleeding or bruising
• Bad taste in the mouth
• Tremor, tics
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face
• Fainting
• A recurring rash
• Bed wetting, pain and/or difﬁculty passing water
Not known side effects
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Increased appetite
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Vertigo
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Urinary retention
Some cases of memory loss and/or impairment have also been reported. In very rare cases people have thought about committing suicide and
if you feel this way then stop taking the tablets and see your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CETIRIZINE HYDROCHLORIDE TABLETS

Important information about some of the ingredients of Cetirizine hydrochloride Tablets
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

Keep out of the reach and sight of children.
Do not use Cetirizine hydrochloride Tablets after the expiry date which is stated on the blister and the carton. The expiry date refers to the last
day of that month.
This medicinal product does not require any special storage conditions.

3. HOW TO TAKE CETIRIZINE HYDROCHLORIDE TABLETS

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Always take Cetirizine hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or your pharmacist if you
are not sure.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Adults, elderly patients and children 12 years and over: 1 tablet daily
Children aged between 6 to 12 years: ½ tablet (5mg) twice daily
Patients with moderate kidney problems: ½ tablet (5mg) once daily
Method of administration
Cetirizine hydrochloride Tablets can be taken with food or without food. The tablets should be swallowed with water.
If you take more Cetirizine hydrochloride Tablets than you should
Contact your doctor or Accident and Emergency department at your nearest hospital. Take this leaflet and any tablets you still have with you.
Symptoms of overdose include confusion, diarrhoea, dizziness, tiredness, feeling generally unwell, dilated pupils, itching, restlessness,
sleepiness, loss of consciousness, tremor, headache, abnormal rapid heart rate or problems passing urine.
If you forget to take Cetirizine hydrochloride Tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

What Cetirizine hydrochloride Tablets contains
The active substance is Cetirizine hydrochloride. Each tablet contains 10 mg of Cetirizine hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc,
hypromellose, titanium dioxide (E171), macrogol 4000 and sodium citrate.
What Cetirizine hydrochloride Tablets looks like and contents of the pack
Cetirizine hydrochloride Tablets are white circular ﬁlm-coated tablets, marked ‘A’ on one side with a break line on the other side and are
available in blister pack containing 7 tablets.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Chanelle Medical.
Loughrea, Co. Galway, Ireland.
The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
The distributor is Aspar Pharmaceuticals., Ltd
This leaﬂet was revised 03/2015.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.